Skip To The Main Content

NYSDA Publications

FDA Issues Draft Guidance on Quantitative Imaging Medical/Dental Devices

The United States Food and Drug Administration (FDA) has issued draft guidance on quantitative imaging medical/dental devices.  The FDA notes that as medical/dental imaging continues to evolve, quantitative imaging – the extraction of information from medical/dental images in the form of numerical values – is increasingly used to assess the severity, degree of change, or status of a disease, injury, or condition.  To read the FDA draft guidance on quantitative imaging medical/dental devices, use the link below.
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM636178.pdf?utm_campaign=2019-04-18%20FDA%20Posts%20Draft%20Guidance%20on%20Technical%20Performance%20Assessment%20of%20Quantitative%20Imaging&utm_medium=email&utm_source=Eloqua
"Local":"NewYorkCountyNY"